FDA.reportPublic FDA data

PMA P030054S390

Device
QuickFlex µ and Quartet
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S390
Product code
NIK
Decision date
2021-03-18
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
Implementation of MCRD component manufacturing process improvements and changes associated with the optimized drug release/elution test method for Isoflex leads.

Current openFDA PMA Record#

Device
QuickFlex µ and Quartet
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S390
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2021-03-18
Decision code
OK30
Date received
2021-02-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of MCRD component manufacturing process improvements and changes associated with the optimized drug release/elution test method for Isoflex leads.